Method and device for treating intrahepatic cholestasis in gestation period through targeted mitochondrial autophagy regulation and control

Abstract

The invention relates to the technical field of medical apparatus and instruments, in particular to a method and device for treating intrahepatic cholestasis in a gestation period through targeted mitochondrial autophagy regulation and control, and the method comprises the following steps: step 1, blood sample collection: collecting a blood sample, and detecting the content of mitochondrial autophagy related biomarkers; 2, data analysis: inputting detection data into a data analysis model, and evaluating the disease risk degree; 3, comprehensive diagnosis: making a diagnosis result according to the risk degree of intrahepatic cholestasis of the patient in the gestation period in combination with clinical symptoms of the patient; and step 4, formulating a treatment scheme: formulating a targeted mitochondrial autophagy regulation and control treatment scheme when the patient is diagnosed as intrahepatic cholestasis in the gestation period according to a diagnosis result. In the diagnosis process of intrahepatic cholestasis in the gestation period, the accuracy and stability of a blood sample can be improved, and sample errors caused by manual operation are reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a method and apparatus for treating intrahepatic cholestasis of pregnancy by targeting mitochondrial autophagy regulation. Background Technology

[0002] Intrahepatic cholestasis of pregnancy (ICP) is a liver disease specific to pregnancy that can lead to serious complications such as premature birth and fetal distress, posing a significant threat to the health of both mother and child. Currently, the clinical diagnosis of ICP mainly relies on the detection of serum bile acid levels.

[0003] Blood sample collection is usually required for serum bile acid level testing. For blood collection, traditional finger-clip blood collection devices, such as the BD Microtainer blood collection device, can be carried by medical staff. The finger-clip blood collection method can complete the peripheral blood collection with a simple pressing operation, which reduces the operation threshold and helps to improve the efficiency of medical work.

[0004] However, existing blood collection devices still suffer from operational complexity. For example, the BD Microtainer blood collection device requires medical staff to manually control the pressure applied during use, which not only increases the difficulty of operation but may also lead to insufficient or excessive blood collection due to improper pressure, affecting the accuracy of test results. Therefore, it is necessary to propose a method and device for targeting mitophagy regulation to treat intrahepatic cholestasis of pregnancy, in order to improve the blood collection efficiency during the diagnosis and treatment of ICP. Summary of the Invention

[0005] To address the aforementioned problems, this invention provides a method and apparatus for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation. This method automatically controls the blood collection process, depth, and volume, thereby improving the accuracy and stability of blood samples during the diagnosis of intrahepatic cholestasis of pregnancy, reducing sample errors caused by human operation, and simultaneously increasing the diagnostic efficiency of intrahepatic cholestasis of pregnancy.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: A method for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation, comprising the following steps: Step 1, Blood Sample Collection: Use the collection unit to collect the patient's blood sample into the collection unit, and use an enzyme-linked immunosorbent assay (ELISA) analyzer to detect the content of biomarkers related to mitophagy in the blood sample.

[0007] Step 2, Data Analysis: Input the content data of biomarkers related to mitophagy in the blood sample into the data analysis model for analysis to obtain the risk level of intrahepatic cholestasis during pregnancy.

[0008] Step 3, Comprehensive Diagnosis: Based on the output risk level and combined with the preset clinical symptom judgment criteria for intrahepatic cholestasis of pregnancy, the data analysis model automatically outputs the patient's diagnostic results.

[0009] Step 4, Treatment Plan Formulation: Based on the automatically output diagnostic results, the system calls up the pre-set database of treatment plans for intrahepatic cholestasis of pregnancy, automatically matches and outputs a treatment plan targeting mitochondrial autophagy regulation.

[0010] The technical principles of the above solution are as follows: The blood collection component enables automated blood sampling from patients. The constructed data analysis model, based on deep learning principles, outputs the corresponding risk probability value for intrahepatic cholestasis of pregnancy when biomarker levels in the patient's blood sample are input, thus achieving a quantitative assessment of disease risk. Combining the disease risk level derived from the data analysis model with clinical symptoms such as pruritus and jaundice, the patient's condition is comprehensively assessed from multiple dimensions. Based on the pathological association between mitophagy and intrahepatic cholestasis of pregnancy, a targeted mitophagy regulation treatment plan is developed after the patient is diagnosed.

[0011] The above approach has the following beneficial effects: 1. This invention automates the blood collection process, depth, and volume, avoiding the reliance on manual pressure in traditional blood collection equipment, thus improving blood collection efficiency and reducing the problem of insufficient or excessive blood collection caused by improper operation by medical staff.

[0012] 2. This invention utilizes a deep learning-based data analysis model that can deeply mine and analyze the content data of biomarkers related to mitophagy in blood samples. The CNN network model automatically extracts key features and establishes a correlation with the degree of disease risk through multi-layer convolution and pooling operations. Compared with traditional diagnostic methods, it can quantitatively assess the risk probability value of intrahepatic cholestasis during pregnancy. Combined with clinical symptoms such as skin itching and jaundice, it provides comprehensive and objective diagnostic evidence from multiple dimensions, improving the accuracy and timeliness of diagnosis.

[0013] 3. Based on the pathological association between mitophagy and intrahepatic cholestasis during pregnancy, this invention formulates a targeted mitophagy regulation and treatment plan. It synergistically regulates mitophagy from multiple aspects to achieve precise targeted treatment of the disease, which can effectively improve the patient's condition and reduce the risk of serious complications such as premature birth or fetal distress.

[0014] Furthermore, in step one, biomarkers associated with mitophagy include one or more of the following proteins: PINK1, Parkin, and LC3-II.

[0015] Beneficial effects: PINK1, Parkin, and LC3-II proteins are key regulators of mitophagy, and changes in their levels directly reflect the level of mitophagy. By detecting these biomarkers, abnormal mitophagy function can be identified in patients with intrahepatic cholestasis of pregnancy.

[0016] Furthermore, in step two, the risk level of intrahepatic cholestasis during pregnancy is determined using a data analysis model, including the following methods: S1. Construct a raw dataset containing known diagnostic results of intrahepatic cholestasis during pregnancy and corresponding PINK1, Parkin, and LC3-II protein content data. Input the raw dataset into a CNN network model for training to obtain a data analysis model.

[0017] S2 inputs the data on the content of biomarkers related to mitophagy in the patient's blood sample into the final data analysis model, outputs the risk probability value of intrahepatic cholestasis during pregnancy, and classifies it into low risk, medium risk and high risk levels according to the preset risk threshold.

[0018] Beneficial effects: Training a CNN network model based on known diagnostic results and biomarker data enables the data analysis model to possess powerful pattern recognition and feature extraction capabilities. It can automatically uncover the non-linear relationship between biomarker levels and disease risk, rapidly converting patient test data into quantified risk probability values ​​and risk levels, reducing the subjectivity and uncertainty of human diagnosis.

[0019] Furthermore, in step three, clinical symptoms include itchy skin and jaundice.

[0020] Beneficial effects: Skin itching and jaundice are typical clinical symptoms of intrahepatic cholestasis of pregnancy. Combining these symptoms with the risk level derived from the data analysis model forms a dual diagnostic basis of "biomarker data + clinical symptoms". Furthermore, in step four, the targeted mitophagy regulation treatment regimen includes one or more of the use of drugs that regulate mitophagy and the regulation of the patient's diet and lifestyle to regulate mitophagy; drugs that regulate mitophagy include rapamycin, rapamycin analogs, and mitochondrial-targeting antioxidants.

[0021] Beneficial effects: Compared with traditional symptom-only treatments, this comprehensive treatment plan can more effectively improve the patient's condition, reduce the risk of serious complications such as premature birth and fetal distress, protect the health of mother and baby, reduce drug side effects, and improve the patient's quality of life.

[0022] Furthermore, a device for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation includes a collection component and a receiving component. The collection component includes a collection clamp consisting of an upper clamp and a lower clamp hinged together. A placement groove for placing a finger is opened between the upper clamp and the lower clamp. A pressing part is fixedly connected to the end of the upper clamp away from the placement groove. A first torsion spring is provided at the hinge of the upper clamp and the lower clamp to provide elastic clamping force so that the upper clamp and the lower clamp hold the patient's finger.

[0023] The upper clamp has a drive chamber, and the inner side wall of the drive chamber has several slots. The bottom of the drive chamber has an adsorption hole. A first piston is slidably fitted inside the drive chamber. A blood collection needle is detachably connected to the bottom of the first piston. A connecting tube is fixedly connected to the top of the first piston, and the connecting tube communicates with the blood collection needle. The first piston is equipped with a safety component for stopping the blood collection needle based on the change in resistance experienced by the blood collection needle. The upper clamp has a drive component for driving the first piston to slide inside the drive chamber.

[0024] Beneficial effects: The placement slot provides an accurate placement position for the finger, and the pressing part makes it easy for medical staff to operate. By pressing the pressing part and placing the patient's finger into the placement slot, the upper and lower clamps can hold the patient's finger, and blood collection can be performed. This reduces the difficulty of operation for medical staff and improves blood collection efficiency.

[0025] Furthermore, the collection assembly includes a vacuum blood collection tube detachably connected to the top of the upper clamp, with the end of the connecting tube away from the blood collection needle connected to the bottom of the vacuum blood collection tube; the upper clamp is also equipped with a storage wheel and a second torsion spring, the storage wheel is rotatably connected to the upper clamp, the second torsion spring is used to reset the storage wheel, and the storage wheel is used to store and wind up the excess connecting tube.

[0026] Beneficial effects: Vacuum blood collection tubes automatically collect blood samples using vacuum negative pressure, avoiding contact between blood and the external environment, effectively preventing sample contamination, and ensuring the originality of the sample and the accuracy of the test results.

[0027] Furthermore, the safety assembly includes a chamber opened inside the first piston, a rotating shaft rotatably fitted on the inner wall of the chamber, a roller sleeved on the rotating shaft, and a spiral limiting block fixedly connected to the roller.

[0028] The first piston is also provided with a drive channel, in which a conical wheel is slidably fitted. A connecting rod is fixedly connected to one side wall of the conical wheel. The end of the connecting rod away from the conical wheel extends through the side wall of the drive channel into the chamber and is symmetrically fitted with a limit wheel. The limit wheel is in rolling fit with a spiral limit block.

[0029] A gear is coaxially fixedly connected to one end of the roller shaft, and the gear meshes with a rack. The rack slides in fit with the side wall of the chamber. A tension spring is fixedly connected to one end of the rack, and a second piston is fixedly connected to the other end of the rack. The end of the tension spring away from the rack is fixedly connected to the top wall of the chamber. A piston chamber is also opened inside the first piston. The piston chamber is connected to the drive chamber. The second piston is located inside the piston chamber and slides in fit with the side wall of the piston chamber.

[0030] Beneficial effects: When the lancet contacts the skin and continues to press down, if it encounters strong resistance when it reaches the appropriate depth, the second piston will trigger the limiting mechanism to prevent the first piston from continuing to slide down, thus automatically stopping the lancet. This avoids injury to the patient due to excessive blood collection, adapts to differences in the skin and tissues of different patients, and ensures the consistency of blood collection depth each time, improving the quality of blood collection and the reliability of test results.

[0031] Furthermore, the drive assembly includes a controller and a power chamber opened in the upper clamping body. A micro pump is fixedly connected inside the power chamber, and the controller is used to control the opening and closing of the micro pump.

[0032] The inlet of the micropump is connected to an air tube, the end of the air tube away from the micropump is connected to the bottom of the drive chamber, the outlet of the micropump is connected to the outside, and a hemostatic component for stopping bleeding on the finger after collecting blood samples is provided on the inner side wall of the placement slot.

[0033] Beneficial effects: The controller precisely controls the opening and closing of the micro pump. The negative pressure generated by the micro pump drives the first piston to slide in the drive chamber, thereby realizing automated blood collection.

[0034] Furthermore, the hemostatic component includes a sterile hemostatic cotton detachably connected to the bottom of the drive chamber.

[0035] Beneficial effects: The hemostatic component can immediately stop bleeding from the patient's finger after blood collection.

[0036] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0037] Figure 1 This diagram illustrates the steps of the method for treating intrahepatic cholestasis of pregnancy by targeting mitochondrial autophagy regulation according to the present invention.

[0038] Figure 2This is an isometric view of the device for treating intrahepatic cholestasis during pregnancy by targeting mitochondrial autophagy regulation according to the present invention.

[0039] Figure 3 This is a side cross-sectional view of the upper clamp of the device for treating intrahepatic cholestasis during pregnancy using targeted mitophagy regulation according to the present invention.

[0040] Figure 4 for Figure 3 Enlarged view of part A in the middle.

[0041] Figure 5 This is an isometric view of the safety component in the device for treating intrahepatic cholestasis during pregnancy using targeted mitophagy regulation, as described in this invention.

[0042] The reference numerals in the accompanying drawings of the instruction manual include: 1. Upper clamp; 2. Lower clamp; 3. Placement groove; 4. Pressing part; 5. Drive chamber; 6. Vacuum blood collection tube; 7. Adsorption hole; 8. First piston; 9. Blood collection needle; 10. Storage wheel; 11. Chamber; 12. Rotating shaft; 13. Roller shaft; 14. Spiral limiting block; 15. Drive channel; 16. Conical wheel; 17. Connecting rod; 18. Limiting wheel; 19. Gear; 20. Rack; 21. Tension spring; 22. Second piston; 23. Piston chamber; 24. Power chamber; 25. Micro pump; 26. Trachea; 27. Sterile hemostatic cotton; 28. Slot. Detailed Implementation

[0043] The following detailed description illustrates the specific implementation method: Implementation, for example, attached Figure 1 The following is a method for treating intrahepatic cholestasis of pregnancy by targeting the regulation of mitophagy, comprising the following steps: Step 1, Blood Sample Collection: A blood sample from the patient is collected using the collection unit. The blood sample is then analyzed using an enzyme-linked immunosorbent assay (ELISA) analyzer to detect the levels of biomarkers related to mitophagy. Biomarkers related to mitophagy include one or more of PINK1 protein, Parkin protein, and LC3-II protein. In this embodiment, the levels of PINK1 protein and Parkin protein are selected as the biomarkers related to mitophagy.

[0044] Step 2, Data Analysis: Input the data on the levels of PINK1 and Parkin proteins in the blood sample into the data analysis model for analysis to obtain the risk level of intrahepatic cholestasis during pregnancy.

[0045] Specifically, data analysis models are used to determine the risk level of intrahepatic cholestasis during pregnancy, including the following methods: S1. Construct a raw dataset containing known diagnostic results of intrahepatic cholestasis during pregnancy and corresponding PINK1, Parkin, and LC3-II protein content data. Input the raw dataset into a CNN network model for training to obtain a data analysis model.

[0046] S2 inputs the data on the content of biomarkers related to mitophagy in the patient's blood sample into the final data analysis model, outputs the risk probability value of intrahepatic cholestasis during pregnancy, and classifies it into low risk, medium risk and high risk levels according to the preset risk threshold.

[0047] Step 3, Comprehensive Diagnosis: Based on the output risk level and combined with the preset clinical symptom judgment criteria for intrahepatic cholestasis of pregnancy, the data analysis model automatically outputs the patient's diagnostic results.

[0048] Step 4, Treatment Plan Formulation: Based on the automatically output diagnostic results, the system calls up the pre-set database of treatment plans for intrahepatic cholestasis of pregnancy, automatically matches and outputs a treatment plan targeting mitochondrial autophagy regulation.

[0049] Specifically, targeted mitophagy regulation therapy includes one or more of the following: using drugs that regulate mitophagy and adjusting the patient's diet and lifestyle to regulate mitophagy; drugs that regulate mitophagy include rapamycin, rapamycin analogs, and mitochondrial-targeting antioxidants.

[0050] The specific implementation process is as follows: Medical staff used disposable sterile blood collection needles equipped with 28G needles (0.36mm outer diameter). The pregnant woman inserted her finger into the collection device to collect a blood sample. After collecting 1ml of blood, the sample was analyzed using an enzyme-linked immunosorbent assay (ELISA) analyzer to detect the levels of PINK1 and Parkin proteins.

[0051] The original dataset (containing 10,000 known diagnostic results and corresponding biomarker content data) was input into a CNN network model and trained for 100 training epochs with a learning rate of 0.001 to obtain the data analysis model. The PINK1 and Parkin protein content data from patient samples were then input into the data analysis model, which outputs risk probability values. Patient risk levels were categorized as follows: low risk <0.3, medium risk 0.3-0.7, and high risk >0.7.

[0052] Inquire in detail about the pregnant woman's persistent skin itching (focusing on the palms and soles), and observe whether jaundice appears in the sclera and skin. If the pregnant woman is in late pregnancy and the data analysis model assesses her as high-risk, and she also has significant skin itching and mild jaundice, combined with liver function test results, intrahepatic cholestasis of pregnancy can be diagnosed. If the risk is low to medium but there are typical symptoms, a repeat examination or further testing is recommended.

[0053] If a patient is diagnosed with intrahepatic cholestasis of pregnancy, a dietary plan will be developed for mild cases, such as consuming 200g of deep-sea fish rich in omega-3 fatty acids and 500g of fresh fruits and vegetables daily, combined with 30 minutes of prenatal yoga daily. For moderate to severe cases, in addition to dietary adjustments, oral rapamycin will be administered (starting dose 0.5mg / day, adjusted according to liver function and blood drug concentration), while monitoring fetal movement and fetal heart rate, and regularly checking liver function and serum bile acid levels to dynamically adjust the treatment plan.

[0054] This invention utilizes a deep learning-based data analysis model to deeply mine and analyze the content data of biomarkers related to mitophagy in blood samples. The CNN network model automatically extracts key features and establishes a correlation with the degree of disease risk through multi-layer convolution and pooling operations. Compared with traditional diagnostic methods, it can quantitatively assess the risk probability value of intrahepatic cholestasis during pregnancy. Combined with clinical symptoms such as skin itching and jaundice, it provides comprehensive and objective diagnostic evidence from multiple dimensions, improving the accuracy and timeliness of diagnosis.

[0055] like Figure 2 and Figure 3 As shown, specifically, the collection component includes a collection clip consisting of an upper clip 1 and a lower clip 2 hinged together. A placement groove 3 for placing a finger is opened between the upper clip 1 and the lower clip 2. A pressing part 4 is integrally formed at the end of the upper clip 1 away from the placement groove 3. A first torsion spring is provided at the hinge of the upper clip 1 and the lower clip 2 to provide elastic clamping force so that the upper clip 1 and the lower clip 2 clamp the patient's finger.

[0056] The upper clamp 1 has a drive cavity 5, and the inner sidewall of the drive cavity 5 has several slots 28. The bottom of the drive cavity 5 has an adsorption hole 7. The drive cavity 5 is slidably fitted with a first piston 8. The bottom of the first piston 8 is detachably connected to a blood collection needle 9. In this embodiment, the blood collection needle 9 is a disposable sterile blood collection needle. A connecting tube is fixedly bonded to the top of the first piston 8, and the connecting tube communicates with the blood collection needle 9. The first piston 8 is provided with a safety component for stopping the blood collection needle 9 based on the change in resistance received by the blood collection needle 9. The upper clamp 1 is provided with a drive component for driving the first piston 8 to slide in the drive cavity 5.

[0057] Since a first torsion spring is provided at the hinge of the upper clamp 1 and the lower clamp 2, when the operator presses down on the pressing part 4, the ends of the upper clamp 1 and the lower clamp 2 away from the pressing part 4 open up to each other. The patient's fingertips are placed into the placement groove 3 with the fingertips facing upwards. When the pressing part 4 is released, the ends of the upper clamp 1 and the lower clamp 2 away from the pressing part 4 close up to each other under the action of the first torsion spring, thereby clamping and fixing the patient's fingers.

[0058] Combination Figure 3 As shown, when the driving component draws gas from the driving chamber 5, a negative pressure is generated inside the driving chamber 5. At this time, the suction hole 7 can adhere to the patient's finger skin, making it more stable and fixed. The negative pressure inside the driving chamber 5 causes the first piston 8 to move downward and insert the blood collection needle 9 at the bottom into the skin of the patient's finger to complete the blood collection operation. After the blood collection operation is completed, the driving component generates a positive pressure inside the driving chamber 5. At this time, the first piston 8 moves upward and causes the blood collection needle 9 to leave the patient's finger skin, which is convenient for the next operation. The detachable blood collection needle 9 at the bottom of the first piston 8 can be replaced, which is convenient for the reuse of the device.

[0059] like Figure 3 As shown, specifically, the collection assembly includes a vacuum blood collection tube 6 detachably connected to the top of the upper clamp 1, with the end of the connecting tube away from the blood collection needle 9 connected to the bottom of the vacuum blood collection tube 6.

[0060] The upper clamp 1 is also provided with a storage wheel 10 and a second torsion spring. The storage wheel 10 is rotatably connected to the upper clamp 1. The second torsion spring is used to reset the storage wheel 10. The storage wheel 10 is used to store and wind up the excess connecting tube.

[0061] When the first piston 8 moves downward, the connecting tube is pulled out of the receiving wheel 10 under the traction of the first piston 8. When the blood collection needle 9 (blood collection ends) is reset, the second torsion spring drives the receiving wheel 10 to rotate under its own potential energy, and recycles the excess connecting tube and winds it around the receiving wheel 10.

[0062] like Figure 4 As shown, specifically, the safety assembly includes a chamber 11 opened inside the first piston 8, a rotating shaft 12 rotatably fitted on the inner wall of the chamber 11, a roller 13 sleeved on the rotating shaft 12, and a spiral limiting block 14 fixedly connected to the roller 13.

[0063] The first piston 8 is also provided with a drive channel 15. A conical wheel 16 is slidably fitted in the drive channel 15. A connecting rod 17 is integrally formed on one side wall of the conical wheel 16. The end of the connecting rod 17 away from the conical wheel 16 extends through the side wall of the drive channel 15 into the chamber 11 and is symmetrically and rotatably fitted with a limiting wheel 18. The limiting wheel 18 is in rolling fit with the spiral limiting block 14.

[0064] One end of the roller 13 is coaxially integrally formed with a gear 19, which meshes with a rack 20. The rack 20 slides with the side wall of the chamber 11. One end of the rack 20 is fixedly connected to a tension spring 21 by a screw, and the other end of the rack 20 is fixedly connected to a second piston 22 by a screw. The end of the tension spring 21 away from the rack 20 is fixedly connected to the top wall of the chamber 11 by a screw. The first piston 8 also has a piston chamber 23, which is connected to the drive chamber 5. The second piston 22 is located in the piston chamber 23 and slides with the inner side wall of the piston chamber 23.

[0065] like Figure 3 As shown, the drive assembly includes a controller and a power chamber 24 opened in the upper clamp 1. A micro pump 25 is fixedly connected in the power chamber 24 by screws. The controller is used to control the opening and closing of the micro pump 25. In this embodiment, the micro pump 25 is a dual-purpose pump that can generate both positive and negative pressure.

[0066] The inlet of the micro pump 25 is connected to the air tube 26. The end of the air tube 26 away from the micro pump 25 is connected to the bottom of the drive chamber 5. The outlet of the micro pump 25 is connected to the outside. The inner wall of the placement slot 3 is provided with a hemostatic component for stopping bleeding on the finger after collecting blood samples.

[0067] Combination Figure 4 and Figure 5 As shown, the controller controls the micro pump 25 to start, which generates negative pressure at the output port, and generates negative pressure in the drive chamber 5. Under the action of negative pressure in the drive chamber 5, the first piston 8 moves downward. During the downward movement of the first piston 8, the blood collection needle 9 pierces the skin of the patient's finger. Since the blood collection needle 9 and the vacuum blood collection tube 6 are connected to each other through the connecting tube, the vacuum blood collection tube 6 can draw blood from the blood collection needle 9 into the vacuum blood collection tube 6. The vacuum blood collection tube 6 is existing technology, and will not be described in detail in this embodiment.

[0068] During the advancement of the blood collection needle 9, the resistance it experiences changes as follows: initially, when puncturing the skin, the blood collection needle 9 experiences initial resistance from the skin surface. As the blood collection needle 9 penetrates deeper into the skin, the resistance from the subcutaneous tissue gradually increases. When the blood collection needle 9 reaches a suitable depth, the resistance reaches a preset threshold. Since the negative pressure of the micro-pump 25 is constant, when the resistance of the first piston 8 increases, the negative pressure in the drive chamber 5 also increases. Because the piston chamber 23 and the drive chamber 5 are connected, the negative pressure in the piston chamber 23 also increases. When the negative pressure in the piston chamber 23 increases to exceed the tension of the tension spring 21, the negative pressure in the piston chamber 23 can drive the second piston 22 downwards, thereby pulling the tension spring 21 and causing the rack 20 to move downwards. At this time, the rack 20 moves downwards, driving the gear 19... Figure 5The roller 13 rotates clockwise, causing the spiral limiting block 14 to rotate clockwise. Since the limiting wheel 18 is in rolling engagement with the spiral limiting block 14, the clockwise rotation of the spiral limiting block 14 drives the limiting wheel 18 to move the connecting rod 17 to the left, thereby driving the cone wheel 16 to the left so that the cone tip of the cone wheel 16 gets stuck in the slot 28 on the inner wall of the drive cavity 5, locking the first piston 8 and restricting the blood collection needle 9 from moving further. At this time, after the vacuum blood collection tube 6 has collected 1ml of blood sample, the controller controls the micro pump 25 to stop running. After the blood collection is completed, the controller controls the micro pump 25 to generate positive pressure at the input port, so that positive pressure is generated in the drive cavity 5, thereby driving the first piston 8 and then the blood collection needle 9 to return to the finger skin surface. At the same time, the second piston 22 moves upward under the action of the tension spring 21 to restore its deformation, driving the cone wheel 16 to return to its original position.

[0069] Specifically, the hemostatic component includes a sterile hemostatic cotton 27 that is detachably connected to the bottom of the drive chamber 5.

[0070] When blood is drawn by puncture needle 9, sterile hemostatic cotton 27 can absorb the blood seeping around puncture needle 9, reducing the risk of wound infection.

[0071] The specific implementation process is as follows: Medical staff insert the blood collection needle 9 through the suction port 7 and detachably mount it to the bottom of the first piston 8.

[0072] The patient places their fingertip upwards in the placement slot 3 between the upper clip 1 and the lower clip 2. The placement slot 3 is 18mm wide, which can accommodate the finger size of most adults. The medical staff presses down on the pressing part 4, and the upper clip 1 and the lower clip 2 close together under the action of the first torsion spring, stabilizing and fixing the patient's finger to prevent the finger from shaking during blood collection.

[0073] Medical staff activate the micro-pump 25 via the controller, generating a constant negative pressure of -0.06 MPa at its output port. The reduced air pressure in the drive chamber 5 creates a negative pressure, causing the first piston 8 to move downwards at a speed of 5 mm / s, thus driving the blood collection needle 9 to puncture the skin. When the blood collection needle 9 contacts the skin, it experiences an initial resistance of 0.5 N. As the puncture deepens, the subcutaneous tissue resistance gradually increases. When the puncture depth reaches 2.5 mm (a preset safe depth), the resistance reaches 0.8 N (a preset threshold). At this point, the negative pressure in the piston chamber 23 increases to -0.07 MPa, exceeding the tension of the tension spring 21 (elastic coefficient 2 N / m). The tension spring 21 is pulled, causing the rack 20 to move downwards. The cone tip of the conical wheel 16 engages in the slot 28, locking the first piston 8 and thus stopping the blood collection needle 9 from moving, ensuring patient safety.

[0074] In existing technologies, it is difficult to detect the insertion depth of the blood collection needle 9 by measuring the insertion pressure. The adaptive mechanism of this invention can adapt to the thickness of the subcutaneous tissue of different patients' fingers, eliminating the need for medical staff to manually adjust the blood collection depth based on individual patient differences. Blood collection can be completed automatically through resistance sensing and mechanical linkage, reducing the complexity of the operation process, lowering the operational difficulty and training costs for medical staff, and improving the efficiency of clinical blood collection. During this process, blood is drawn into the vacuum blood collection tube 6 through the connecting tube, completing a 1ml blood collection.

[0075] After blood collection, medical staff control the micro-pump 25 to generate a positive pressure of 0.03 MPa at the inlet. The air pressure inside the drive chamber 5 increases, and the first piston 8 moves upward at a speed of 6 mm / s under the positive pressure, causing the blood collection needle 9 to leave the finger skin. At the same time, the second piston 22 moves upward under the action of the tension spring 21 to restore its deformation, causing the conical wheel 16 to retract, disengage from the slot 28, and return to its initial position, preparing for the next blood collection.

[0076] Medical staff removed the vacuum blood collection tubes (6) filled with blood samples from the device, labeled them, and sent them to the laboratory for analysis using an enzyme-linked immunosorbent assay (ELISA) analyzer to detect the levels of biomarkers related to mitophagy in the blood samples. Standardized samples reduce detection errors caused by insufficient blood volume or excessive tissue fluid contamination when detecting mitophagy-related biomarkers. Comparative experiments showed that the dispersion of detection results using this device was reduced by 20% compared to traditional equipment.

[0077] This invention automates the blood collection process, depth, and volume, avoiding the reliance on manual pressure in traditional blood collection equipment, thus improving blood collection efficiency and reducing the problem of insufficient or excessive blood collection caused by improper operation by medical staff.

[0078] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A method for treating intrahepatic cholestasis of pregnancy by targeting the regulation of mitophagy, characterized in that, Includes the following steps: Step 1, Blood Sample Collection: Use the collection unit to collect the patient's blood sample into the collection unit, and use an enzyme-linked immunosorbent assay (ELISA) analyzer to detect the content of biomarkers related to mitophagy in the blood sample. Step 2, Data Analysis: Input the content data of biomarkers related to mitophagy in the blood sample into the data analysis model for analysis to obtain the risk level of intrahepatic cholestasis during pregnancy in patients; Step 3, Comprehensive Diagnosis: Based on the output risk level and combined with the preset clinical symptom judgment criteria for intrahepatic cholestasis of pregnancy, the data analysis model automatically outputs the patient's diagnostic results. Step 4, Treatment Plan Formulation: Based on the automatically output diagnostic results, the pre-set database of treatment plans for intrahepatic cholestasis of pregnancy is invoked, and a targeted mitophagy regulation treatment plan is automatically matched and output.

2. The method for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation according to claim 1, characterized in that, In step one, biomarkers associated with mitophagy include one or more of the following proteins: PINK1, Parkin, and LC3-II.

3. The method for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation according to claim 2, characterized in that, In step two, the risk level of intrahepatic cholestasis during pregnancy is determined using a data analysis model, including the following methods: S1. Construct an original dataset containing known diagnostic results of intrahepatic cholestasis of pregnancy and corresponding PINK1 protein, Parkin protein, and LC3-II protein content data. Input the original dataset into a CNN network model for training to obtain a data analysis model. S2 inputs the data on the content of biomarkers related to mitophagy in the patient's blood sample into the final data analysis model, outputs the risk probability value of intrahepatic cholestasis during pregnancy, and classifies it into low-risk, medium-risk and high-risk levels according to the preset risk threshold.

4. The method for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation according to claim 3, characterized in that, In step three, clinical symptoms include itchy skin and jaundice.

5. The method for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation according to claim 4, characterized in that, In step four, the targeted mitophagy regulation treatment regimen includes one or more of the use of drugs that regulate mitophagy and the regulation of the patient's diet and lifestyle to regulate mitophagy; drugs that regulate mitophagy include rapamycin, rapamycin analogs, and mitochondrial-targeting antioxidants.

6. A device for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation, characterized in that, The method for targeted mitophagy regulation therapy for intrahepatic cholestasis during pregnancy according to any one of claims 1-5 is performed, wherein the collection component includes a collection clamp consisting of an upper clamp (1) and a lower clamp (2) hinged together, a placement groove (3) for placing a finger is provided between the upper clamp (1) and the lower clamp (2), and a pressing part (4) is fixedly connected to one end of the upper clamp (1) away from the placement groove (3); a first torsion spring is provided at the hinge of the upper clamp (1) and the lower clamp (2) to provide elastic clamping force so that the upper clamp (1) and the lower clamp (2) clamp the patient's finger. The upper clamp (1) has a drive cavity (5) inside, and several slots (28) are opened on the inner side wall of the drive cavity (5). The bottom of the drive cavity (5) has an adsorption hole (7). The first piston (8) is slidably fitted inside the drive cavity (5). The bottom of the first piston (8) is detachably connected to a blood collection needle (9). The top of the first piston (8) is fixedly connected to a connecting tube, which communicates with the blood collection needle (9). The first piston (8) is provided with a safety component for stopping the blood collection needle (9) based on the change in resistance received by the blood collection needle (9). The upper clamp (1) is provided with a drive component for driving the first piston (8) to slide inside the drive cavity (5).

7. The device for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation according to claim 6, characterized in that, The collection assembly includes a vacuum blood collection tube (6) detachably connected to the top of the upper clamp (1), with the end of the connecting tube away from the blood collection needle (9) connected to the bottom of the vacuum blood collection tube (6); The upper clamp (1) is also provided with a storage wheel (10) and a second torsion spring. The storage wheel (10) is rotatably connected to the upper clamp (1). The second torsion spring is used to reset the storage wheel (10). The storage wheel (10) is used to store and wind the excess connecting tube.

8. The device for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation according to claim 7, characterized in that, The safety assembly includes a chamber (11) opened in the first piston (8), a rotating shaft (12) rotatably fitted on the inner side wall of the chamber (11), a roller (13) sleeved on the rotating shaft (12), and a spiral limiting block (14) fixedly connected to the roller (13). The first piston (8) is also provided with a drive channel (15), and a conical wheel (16) is slidably fitted in the drive channel (15). A connecting rod (17) is fixedly connected to one side wall of the conical wheel (16). The end of the connecting rod (17) away from the conical wheel (16) passes through the side wall of the drive channel (15) and extends into the chamber (11) and is symmetrically fitted with a limiting wheel (18). The limiting wheel (18) is rolled in cooperation with the spiral limiting block (14). A gear (19) is coaxially fixedly connected to one end of the roller (13). The gear (19) meshes with a rack (20). The rack (20) slides with the side wall of the chamber (11). A tension spring (21) is fixedly connected to one end of the rack (20). A second piston (22) is fixedly connected to the other end of the rack (20). The end of the tension spring (21) away from the rack (20) is fixedly connected to the top wall of the chamber (11). A piston chamber (23) is also opened in the first piston (8). The piston chamber (23) is connected to the drive chamber (5). The second piston (22) is located in the piston chamber (23) and slides with the side wall of the piston chamber (23).

9. The device for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation according to claim 8, characterized in that, The drive assembly includes a controller and a power chamber (24) opened in the upper clamp (1). A micro pump (25) is fixedly connected in the power chamber (24). The controller is used to control the opening and closing of the micro pump (25). The inlet of the micro pump (25) is connected to the trachea (26). The end of the trachea (26) away from the micro pump (25) is connected to the bottom of the drive chamber (5). The outlet of the micro pump (25) is connected to the outside. The inner wall of the placement slot (3) is provided with a hemostatic component for stopping bleeding on the finger after collecting blood samples.

10. The device for treating intrahepatic cholestasis of pregnancy by targeting mitophagy regulation according to claim 9, characterized in that, The hemostatic assembly includes a sterile hemostatic cotton (27) that is detachably connected to the bottom of the drive chamber (5).

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